Clinical Operations Manager (m/w/d) at Erbe Elektromedizin GmbH
berlin, Berlin, Germany -
Full Time


Start Date

Immediate

Expiry Date

26 Nov, 26

Salary

0.0

Posted On

28 Aug, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Industry

Healthcare & Life Sciences

Description

About this job

For our location in Tübingen, we are looking for someone for the research and basic technology department.

Clinical Operations Manager (m/w/d)

Your responsibility

  • Selection and interaction with external vendors (e.g., CRO, EDC providers)
  • Auditing and monitoring of testing centers, co-monitoring, and auditing of vendors
  • Guidance and support in submitting study applications as well as in the administration and negotiation of study agreements.
  • Planning and execution of national and international preclinical and clinical studies (according to MDR, GCP, and relevant ICH and FDA guidelines) in collaboration with our interdisciplinary research team and the quality management and marketing departments.
  • Preparation of clinical trial protocols, clinical study reports and scientific publications
  • Ensuring compliance with regulatory quality requirements
  • Creation of templates and SOPs for clinical trials according to, among others, ISO 14155, MDR and FDA guidelines.
  • Contact persons for examining physicians and medical cooperation partners as well as non-medical staff

Your qualifications

  • Successfully completed studies in human medicine, human biology or a similar natural science degree
  • Several years of experience in monitoring and submitting study documents
  • Professional experience in the organization and execution of preclinical and clinical studies
  • A good understanding of regulatory requirements in the context of preclinical and clinical studies, ideally for medical device studies.
  • Enjoyment of working with people, data and numbers in an international environment
  • Strong organizational and communication skills
  • Teamwork skills and flexibility
  • Willingness to travel
  • Fluent English skills and good German skills
We offer you:
  • A wide range of health management offerings, including cooking classes, health days, vaccination campaigns, and gym memberships.
  • Electric vehicle charging stations and free parking spaces
  • Challenging tasks and a high degree of personal responsibility
  • Multicultural and international collaboration as well as the opportunity for agile working.
  • Attractive monthly compensation
  • Flexible working hours and the option to work hybrid
  • Onboarding with an introductory event and individual training plan, as well as a wide range of internal and external training opportunities.
  • Social, societal and resource-conserving responsibility
Have we sparked your interest?
  • We look forward to receiving your application, including your salary expectations and earliest possible start date. Please apply via our career portal.
Responsibilities
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